Workshop #1

Case #1 Firm name: Good Injectables, Inc. Product: Manufacturer of aseptically filled vials of injectable solutions. Problem: Environmental OOS Event: On 3/4/2010 two surface samples collected on 3/1/2010 from aseptic core floor exceeded established microbial count specifications, organism identified as bacterium dificil. A week earlier the same microorganism was found on surface samples from floor in the equipment transfer room.

Evaluate case and determine: 1. What regulations apply concerning investigation requirements? 2. What guidance sections apply? 3. What reporting requirements apply? Why? When was report needed? 4. Is a health hazard evaluation needed? 5. Immediate correction or corrective action required? 6. What additional basic information is needed? 7. List probable root causes 8. Indicate additional information needed to confirm/refute identified possible causes

Workshop #2
Case #1 Firm name: Good Injectables, Inc. Manufacturer of aseptically filled vials of injectable solutions Problem: Operator error Additional facts: Historical data indicates than during the week of 11/09/2009 one floor sample from the de-gowning room and two floor samples from the aseptic core floor exceeded total count specifications. The most probable cause identified was poor sample techniques used by the operator when conducting environmental monitoring. Correction consisted of cleaning and disinfecting the floors and equipment. Corrective action: operator was reminded to follow proper aseptic techniques. Lots manufactured were tested and met specifications. Subsequent surface samples showed no contamination.

Evaluate additional information provided determine the following: 1. Was this additional info helpful? How? 2. Is a CAPA required? Why? 3. Indicate corrections, corrective actions and preventive actions needed. 4. Add or delete possible root causes, considering new information. 5. Was a root cause identified? 6. Select one root cause and indicate supporting evidence needed to confirm it.

Workshop #1
Case #2 Firm name: Healthy Tabs, Inc. Manufacturer of tablets by direct compression Products: Alpha (anticoagulant) 3, 6, 10 mg tablets Problem: Packaging error. Event: On 1/4/2011 the firm was informed by a distributor that on 12/17/2010 a pharmacist had reported receiving a bottle labeled Alpha 3 mg tablets, lot #123, that contained Alpha 10 mg tablets. Pharmacist has 5 additional bottles in stock.

Evaluate case and determine: 1. What regulations apply concerning investigation requirements? 2. What guidance sections apply? 3. What reporting requirements apply? Why? When was report needed? 4. Is a health hazard evaluation needed? 5. Immediate correction or corrective action required? 6. What additional basic information is needed? 7. List probable root causes 8. Indicate additional information needed to confirm/refute identified possible causes.

Workshop #2
Case #2 Firm name: Healthy Tabs, Inc. Manufacturer of tablets by direct compression Problem: Packaging error Additional facts: Distributor did not have lot in stock. Pharmacist indicated that one additional Alpha 3 mg bottle in stock is lot #123, the other four bottles lot #567. Alpha 3 mg tablets are white and 10 mg are blue.

Evaluate additional information provided determine the following: 1. Was this additional info helpful? How? 2. Is a CAPA required? Why? 3. Indicate corrections, corrective actions and preventive actions needed. 4. Add or delete possible root causes, considering new information 5. Was a root cause identified? 6. Select one root cause and indicate supporting evidence needed to confirm it.

Workshop #1
Case #3 Firm Name: Fine Devices, Corp. Products: Electronic implantable medical device (pacemaker) Problem: Malfunction Event: Firm received a report from a physician reporting explanting a pacemaker from an 82 year old patient due to malfunction, and replacing with a new unit. The patient died two day later. Patient came for f/u visit but reported several incidents of severe chest pain. Physician reported the pacemaker battery charge had depleted after two years of implantation. According to the device manual, the battery charge should last from 3 to 5 years. Evaluate case and determine: 1. What regulations apply concerning investigation requirements? 2. What guidance sections apply? 3. What reporting requirements apply? Why? When was report needed? 4. Is a health hazard evaluation needed? 5. Immediate correction or corrective action required? 6. What additional basic information is needed? 7. List probable root causes 8. Indicate additional information needed to confirm/refute identified possible causes.

Workshop #2
Case #3 Firm Name: Fine Devices, Corp. Products: Electronic implantable medical device (pacemaker) Problem: Malfunction Additional facts: Device performance, such as frequency of activation, activation time, and battery charge is registered in the device memory and may be extracted at a later time. Physician can access this information from the pacemaker using a wand, a device that is placed on the chest of the patient, directly over the implanted device.

Evaluate additional information provided determine the following: 1. Was this additional info helpful? How? 2. Is a CAPA required? Why? 3. Indicate corrections, corrective actions and preventive actions needed. 4. Add or delete possible root causes, considering new information 5. Was a root cause identified? 6. Select one root cause and indicate supporting evidence needed to confirm it.

Workshop #1
Case #4 Firm Name: Prime Care, Inc. Product: Amiplin 50 mg. (for lowering high blood pressure) Product has a 36 month expiration date and production began in June 2008 Problem: Lack of effectiveness Event: During the month of November and December 2010 the firm received several complaints reporting lack of effectiveness. Products involved: Amiplin 50 mg tablets, Lots #A123 and #A456, expiration date June and August 2011, respectively. According to complaint investigation report the firm had reviewed batch records and reported both lots had met assay and dissolution specifications. Stability data on lot #A123 met potency and dissolution specifications. Reserve samples tested met specification.

Evaluate case and determine: 1. What regulations apply concerning investigation requirements? 2. What guidance sections apply? 3. What reporting requirements apply? Why? When was report needed? 4. Is a health hazard evaluation needed? 5. Immediate correction or corrective action required? 6. What additional basic information is needed? 7. List probable root causes 8. Indicate additional information needed to confirm/refute identified possible causes.

Workshop #2
Case #4 Firm Name: Prime Care, Inc. Product: Amiplin 50 mg. (for lowering high blood pressure) Product has a 36 month expiration date and production began in June 2008 Problem: Lack of effectiveness Additional facts: Soon after this incident an internal audit revealed that the firm had not been using a stability indicating method for dissolution and potency tests. A new stability test method was developed and tests conducted with the new method revealed that the active ingredient was present in two crystal forms with different solubility characteristics.

Evaluate additional information provided determine the following: 1. Was this additional info helpful? How? 2. Is a CAPA required? Why? 3. Indicate corrections, corrective actions and preventive actions needed. 4. Add or delete possible root causes, considering new information 5. Was a root cause identified? 6. Select one root cause and indicate supporting evidence needed to confirm it.

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Case #5 Firm name: Great Devices Inc. Product : Administration sets Problem: Operator error Event: On February 18, 2011 QA reported that several lots manufactured that week had failed the pull test, units were separating at the Y site. The Y site is attached as part of a sub assembly. Investigation revealed that the failing lots had used sub-assemblies manufactured in October 2010. Products manufactured using sub-assemblies manufactured in December 2010 had no failures. Device History Records for the sub-assembly lots revealed no discrepancies; all lots had passed the pull test.

Evaluate case and determine: 1. What regulations apply concerning investigation requirements? 2. What guidance sections apply? 3. What reporting requirements apply? Why? When was report needed? 4. Is a health hazard evaluation needed? 5. Immediate correction or corrective action required? 6. What additional basic information is needed? 7. List probable root causes 8. Indicate additional information needed to confirm/refute identified possible causes

Workshop #2
Case #5 Firm name: Great Devices Inc. Product : Administration sets Problem: Operator error

Additional facts: The firm destroyed all failing lots and their remaining stock of October subassemblies. Operators were re-trained on proper assembly techniques using solvents and visual inspections. Upon questioning the supplier of the solvent, the investigation revealed that the supplier had changed his solvent supplier as of January 2010 and had notified the manufacturer by e-mail. There was evidence the information had been reviewed by QA. It was further determined that sub-assemblies are used usually within a month from manufacturing, but the sub-assemblies involved in the event had been in storage for over three months. There were several complaints in file reporting leaks at the Y site.

Evaluate additional information provided determine the following: 1. Was this additional info helpful? How? 2. Is a CAPA required? Why? 3. Indicate corrections, corrective actions and preventive actions needed. 4. Add or delete possible root causes, considering new information 5. Was a root cause identified? 6. Select one root cause and indicate supporting evidence needed to confirm it.